BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 5277539 · Received December 9, 2015

    Report

    Report Number
    1219930-2015-01062
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 12, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS WERE REPORTED IN ERROR. ACTUAL PRODUCTS REPORTED: EGIA45AMT PRODUCT, LOT #: N3C0403LX ; EGIA 45 ARTICULATING MED/THICK SULU, K083519. IDRVULTRA1 PRODUCT, SERIAL # (B)(4); IDRIVE ULTRA POWERED HANDLE 1, K121510. EGIAADAPT PRODUCT, SERIAL #: (B)(4); ENDO GIA ADAPTER STANDARD.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION ONE RELOAD. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE RELOAD LOADED, UNLOADED, ROTATED, ARTICULATED, AND OPENED AND CLOSED PROPERLY WITHOUT DIFFICULTY. THE INTERLOCK WAS OVERRIDDEN AND THE RELOAD WAS THEN APPLIED TO TEST MEDIA, AND FOUND TO FUNCTION PROPERLY. ALL STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY TRANSECTED. FUNCTIONAL TESTING CONFIRMED THE SAFETY INTERLOCK FEATURE SUCCESSFULLY PREVENTED THE RELOAD FROM CYCLING AGAIN. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. REPLICATION OF THE PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE FIRING BUTTON HAD BEEN PRESSED AND THEN THE OPEN BUTTON WAS PRESSED AFTER PRESSING THE GREEN FIRING BUTTON. IN THIS SITUATION, THE SAFETY INTERLOCK FEATURE WILL ENGAGE AND PREVENT THE LOADING UNIT FROM FIRING A SECOND TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAP HEPATECTOMY PROCEDURE, A (B)(4) WAS ASSEMBLED TO THE IDRIVE ULTRA STAPLER, THE JAW WAS CLOSED ON THE HEPATIC PEDICLE AND A GREEN STATUS LIGHT WAS ON. THE RELOAD WAS FIRED. HOWEVER,THE IDRIVE ULTRA STAPLER COULD NOT SUCCESSFULLY FIRE TO THE END AND IT STOPPED WHEN THE I-BEAM HIT THE TISSUE. SURGEON ATTEMPTED TO PRESS THE FIRE BUTTON CONTINUALLY BUT I-BEAM COULD NOT MOVE FORWARD. THE RELOAD UNIT WAS WITHDRAWN AND REPLACED WITH A (B)(4) BUT SAME THING HAS HAPPENED AGAIN. FINALLY, SURGEON DECIDED TO TRANSECT THE PEDICLE WITH A MANUAL (B)(4) STAPLER AND A NEW RELOAD. THE (B)(4) AND (B)(4) WERE RETURNED TO OFFICE FOR INVESTIGATION. NO PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807986 EGIA 45 ARTICULATING MED/THICK SULU STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA45AMT N3C0403LX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR